Coronary Artery Disease Clinical Trial
Official title:
A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula
This is a single center, prospective study:
The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the
control group.
Patients referred for CPB procedure will be offered to participate in the study. Patients
will be asked to sign an informed consent form (ICF), prior to performing any study related
procedures.
The point of enrollment is the time at which a patient signs and dates the ICF. Following
enrollment, the patient will undergo screening evaluation (including Neurological
assessment) to determine eligibility. Screening failures will be identified on a screening
log. Patients who are found to meet all inclusion criteria and none of the exclusion
criteria will compose the evaluable cohort of the study. Screening failure subjects will not
be counted as part of the target patient sample size nor will they be included in the
analysis.
Patients in the randomized phase will have surgery with the CardioGard Cannula or comparator
cannulae and will remain blinded to their group assignment through the 30 days follow-up
evaluation.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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